REFERENCE CODE GDHC81PIDR | PUBLICATION DATE FEBRUARY 2014
SCHIZOPHRENIA – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Schizophrenia: Key Metrics in the Seven Major The table above provides a summary of the key Pharmaceutical Markets, 2012–2022 metrics for schizophrenia in the seven major 2012 Epidemiology pharmaceutical markets during the forecast period Prevalent population 2.5 million from 2012–2022. Treated population 2.0 million 2012 Market Sales Schizophrenia Drug Sales by Region, 2012– US $5.2bn 2022 5EU $0.4bn Japan $0.7bn The combined sales of medications carrying an Total $6.3bn indication in schizophrenia were estimated at $6.3 Pipeline Assessment billion in 2012. By 2022, GlobalData projects these Number of drugs in Phase II–III 11 sales to grow to $7.9 billion, with a compound Number of first-in-class drugs 2 annual growth rate (CAGR) of 2.40% over the Peak-Year Promising Pipeline Candidates Sales course of the decade. These estimates cover the Brexpiprazole (Otsuka/Lundbeck) $1.8bn sales in the seven major markets (7MM) included Cariprazine (Forest/Gedeon Richter) $0.9bn in this report: the US, France, Germany, Italy, EVP-6124 (EnVivo/Mitsubishi Tanabe) $0.8bn Aripiprazole lauroxil (Alkermes) $0.7bn Spain, the UK, and Japan. We believe that the Invega Sustenna (Three-Month) $0.6bn following parameters will drive expansion in these Level of Key Events (2012–2022) markets: Impact Zyprexa (olanzapine) patent expiry in the ↓↓ Growing awareness of mental health 5EU in 2012 Seroquel (quetiapine) patent expiry in the US ↓↓ Enhanced community-level mental health care and 5EU in 2012 Geodon (ziprasidone) patent expiry in the US ↓ New product launches in 2012 Launch of Abilify Maintena (aripiprazole) in ↑↑↑ Increasing utilization of long-acting injectable the US in 2013 Abilify (aripiprazole) patent expiry in the US (LAI) antipsychotics ↓↓↓ and 5EU in 2015 2022 Market Sales US $6.1bn 5EU $0.4bn Japan $1.4bn 7MM $7.9bn Source: GlobalData. 7MM = US, France, Germany, Italy, Spain, UK, Japan; 5EU = France, Germany, Italy, Spain, UK
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SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
The figure below illustrates schizophrenia drug Positive Symptom Therapies Dominate the sales in the 7MM by region during the forecast Schizophrenia Drug Market period. The pharmaceutical market for schizophrenia Schizophrenia Drug Sales by Region, 2012–2022 is composed solely of symptomatic therapies
2012 that confer significant improvements in positive
11% symptoms, but have little effect on negative
6% and cognitive symptoms of the disease. US Patients with schizophrenia have varying 5EU symptomatologies; negative-dominant Japan schizophrenia or cases with pronounced cognitive impairments are generally untreated by the current market options. In recognition of 83% the unmet therapeutic needs, current research 2022 and development (R&D) efforts are focused on 18% developing drugs with novel mechanisms that target negative and cognitive symptom 5% US clusters. Several key players in the industry 5EU
Japan have concentrated on the two features of the disease that are currently without treatment
77% options: cognitive and negative symptoms. However, several of these novel mechanisms Source: GlobalData. in development are yet to be proven in clinical
trials. Given the growing list of late-stage clinical trial failures, developing pharmacotherapies for negative and cognitive symptoms has proven to be challenging, but those agents that do emerge from the developmental landscape are poised to make a notable impact on the market and see substantial returns year-on-year.
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SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
The current schizophrenia drug The figure below provides an analysis of the armamentarium consists of first-generation and company portfolio gap in schizophrenia during the atypical antipsychotic medications. Due to the forecast period. high competition in the schizophrenia drug Company Portfolio Gap Analysis in Schizophrenia, market, new agents in the market have failed 2012–2022 to meet the needs of psychiatrists and their patients with schizophrenia. However, during the forecast period, the schizophrenia drug High market will encounter rapid changes as a result of patent expirations of key atypical products, Current Players and the companies that have led the market Current and Future Players Future Players will be challenged to maintain their positions. By now, physicians have an established Strength of Marketed Products Marketedof Strength Low familiarity with these courses of therapy. Product-line extensions have helped to increase brand awareness as well as offering Low High Strength of Pipeline different dosage forms that may help clinicians Source: GlobalData. achieve better treatment response. As LAIs are
becoming increasingly utilized, product extensions, along with novel product launches, Unmet Needs are poised to emerge during the forecast The current schizophrenia market relies on period and become significant players in the first-generation antipsychotics (FGA) and schizophrenia drug market. atypical therapies that do not adequately Adjunct therapies are being pursued by several satisfy the needs of patients with the disease. companies. Add-on therapies may provide While these drugs can confer improvements in more complete symptomatic treatment by the patient’s positive symptoms like employing novel mechanisms. There is ample hallucinations and delusions, they do not space within the schizophrenia drug market for improve a patient with a flat emotional affect or therapies that can maintain efficacy more pronounced cognitive impairments, which can efficiently and with greater duration. disrupt a patient’s response to their treatment. The pipeline consists of several candidates that target negative and cognitive symptoms
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SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
and several new LAI therapies. Given the with a chronic antipsychotic treatment regimen. fierce competition in the indication, however, In addition, there are challenges in identifying they will have to demonstrate in clinical trials persistent negative and cognitive symptoms in and in practice that their utility surpasses those patients with schizophrenia. Supplementing of current market options. diagnosis with objective lab variables or biomarkers may help to identify treatment- An additional challenge facing schizophrenia is resistant, negative-predominant, cognitively the social stigma of mental health conditions in impaired, or suicidal patients, allowing for many areas of the world. The level of unmet treatments to be designed more specifically to need in schizophrenia and related mental meet their clinical needs. health disorders is one of the highest in medicine today, but the pharmaceutical Improving the ease-of-use, efficacy, and industry recognizes schizophrenia negative- duration of FGA and atypical therapies will symptom and cognitive-symptom therapeutics increase the quality of life (QOL) and treatment as “high-risk” investments. Consequently, response for patients with schizophrenia. government and academic institutions have However, oral administration of drugs can be stepped forward to become the key difficult in acutely exacerbated patients. contributors to R&D. Their contributions may Offering patients therapy in dosage forms that drive drug development by offering a better require less-frequent dosing or providing drugs understanding of the disease’s molecular with easier routes of administration can directly biology that provides the industry with novel affect their quality of care by improving targets for pharmacotherapy. medication compliance and relieving the demands on psychiatric healthcare services. Ample Market Opportunity The costs associated with novel LAI therapies As drug development shifts from dopamine are anticipated to be several-fold higher than and serotonin receptor blockade to new those of the current oral medications, several mechanisms of action, the need for curative of which are available as generics. Given that therapy will remain for patients with most patients with schizophrenia rely to some schizophrenia. However, it is not expected that extent on government-funded insurance a cure for schizophrenia will be developed by programs, it is especially important that cost- the current agents in the pipeline. minimization measures be implemented and Schizophrenia diagnosis remains a challenge, LAIs be prescribed appropriately to mitigate and first-episode psychosis is not usually met the costs associated with relapse.
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SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
The Direction of Drug Development glycine. However, several challenges stand in the way of pipeline agents for negative- Alkermes’ aripiprazole lauroxil and Invega symptom predominant schizophrenia, such as Sustenna (Three-Month) will introduce two new a lack of effective identification and monitoring LAI treatment options, expanding market of these symptoms. options by 33%. Aripiprazole lauroxil achieves
a formulation advantage over EnVivo’s EVP-6124 is a first-in-class α7 Otsuka/Lundbeck’s Abilify Maintena, given that nicotinic acetylcholine receptor (nAChR) it does not require reconstitution with water agonist in development for cognitive symptoms before it is administered. A three-month associated with schizophrenia. EVP-6124 version of J&J’s Invega Sustenna will provide sensitizes the α7 receptor, making it possible patients with a reduced dosing burden. As for smaller amounts of acetylcholine (ACh) to novel products in an emerging part of the be effective in activating the α7 receptor. schizophrenia drug market, these agents could Unlike the current agents that target primarily be met with high sales due to their higher costs dopaminergic and serotonergic receptor sites, of therapy and a growing popularity of LAIs in EVP-6124 works on a new monoamine system the space. and may potentiate the effects of FGA and atypical medications. We expect EVP-6124 to Otsuka’s brexpiprazole is a follow-up product be used generally in combination with to the current market leader, Abilify marketed antipsychotics. Given its effects on a (aripiprazole). With an improved tolerability current unmet therapeutic need, we project profile and enhanced efficacy over Abilify, that EVP-6124 can yield solid sales that will brexpiprazole’s introduction to the market peak after the forecast period closes. could be met with rapid uptake from the high number of patients currently taking Abilify.
Roche/Chugai’s bitopertin will introduce a new class of medications to the schizophrenia drug market, and the first therapy for schizophrenia’s negative symptoms. As a first- in-class Glycine Transporter Type-1 (Glyt-1), bitopertin is expected to improve negative symptoms and suboptimally controlled positive symptoms by enhancing N-methyl-D-aspartate (NMDA) receptor activity via the regulation of
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SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
The figure below provides a competitive “There isn’t that much coming out these days, so assessment of the late-stage pipeline agents in that’s a fact which many of us have actually agreed schizophrenia during the forecast period. on is a major, major issue. We’ve had discussions with pharmaceutical companies as a group of Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012–2022 pharmacologically oriented and research-oriented psychiatrists and say, ‘Please come back and Brexpiprazole reactivate your research and development sections EVP-6124 Invega Sustenna Three-Month
High and divisions. Don’t desert this group of patients, Cariprazine Aripiprazole lauroxil because we need better drugs.’ There’s no doubt Zicronapine Abilify Maintena about it.”
[US] KOL, September 2013
Commercial Attributes Commercial Bitopertin
Low “If you look at the utilization patterns of antipsychotics you do see that once the atypicals
Low High were introduced, the usage of these medications Clinical Attributes went up significantly. And this is not at all because Note: Bubble size represents approximate peak year sales of pipeline drug there are more schizophrenic patients around. In Source: GlobalData. fact, schizophrenia has actually decreased slightly
in terms of epidemiology. But they have increased What Do the Physicians Think? in terms of rate of prescribing because the “Unfortunately there is really nothing out there diagnosis has expanded to which these which would give me confidence that we will have medications are directed to.”
something reasonably effective in the next several [EU] KOL, November 2013 years. We are probably coming to one set of results very soon, probably sometime early next year or maybe the spring of next year, the glutamatergic compounds.”
[US] KOL, October 2013
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SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
“[We] treat them according to the presenting “Going systematically, you have the glutamatergic syndrome. And even more specifically – in terms of compounds, you have nicotinic acid agonists, you
the positive symptoms, depression, affective have the me-too drugs, which are the D2/5-HT2 symptoms, or cognitive symptoms, negative antagonists, and of those we have plenty, we don’t symptoms – they will be cueing in much more on need anything more, that mechanism of action is that rather than on the label of, ‘Is this entirely taken care of, so to speak.” schizoaffective, is it bipolar, is it a schizophrenic [US] KOL October, 2013 patient?’ I think once it gets down to medications,
then it gets much simpler. These discussions do not reach into the medication decision-making process.”
[EU] KOL, December 2013
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GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
1 Table of Contents
1 Table of Contents ...... 9 1.1 List of Tables ...... 16
1.2 List of Figures ...... 21
2 Introduction ...... 22 2.1 Catalyst ...... 22
2.2 Related Reports ...... 23
2.3 Upcoming Reports ...... 23
3 Disease Overview ...... 24 3.1 Etiology and Pathophysiology ...... 24
3.1.1 Etiology ...... 24 3.1.2 Pathophysiology ...... 25 3.2 Symptoms ...... 26
4 Epidemiology ...... 27 4.1 Disease Background ...... 27
4.2 Risk Factors and Comorbidities ...... 28
4.2.1 Psychiatric illness in first-degree relatives is a strong predictor of schizophrenia ...... 29 4.2.2 Advancing paternal age increases the risk of schizophrenia in offspring ...... 30 4.2.3 Psychiatric comorbidities are common in patients with schizophrenia ...... 31 4.2.4 People with schizophrenia suffer from several medical comorbidities ...... 32 4.3 Global Trends ...... 35
4.3.1 US ...... 38 4.3.2 5EU ...... 39 4.3.3 Japan...... 42 4.4 Forecast Methodology ...... 43
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4.4.1 Sources Used ...... 43 4.4.2 Sources Not Used...... 46 4.4.3 Forecast Assumptions and Methods, Prevalent Cases ...... 46 4.5 Epidemiological Forecast of Schizophrenia (2012–2022) ...... 48
4.5.1 Diagnosed Prevalent Cases of Schizophrenia ...... 48 4.5.2 Age-Specific Prevalent Cases of Schizophrenia ...... 50 4.5.3 Sex-Specific Prevalent Cases of Schizophrenia ...... 52 4.5.4 Age-Standardized Diagnosed Prevalence of Schizophrenia ...... 54 4.6 Discussion ...... 55
4.6.1 Epidemiological Forecast Insight ...... 55 4.6.2 Limitations of the Analysis ...... 56 4.6.3 Strengths of the Analysis ...... 57 5 Disease Management...... 58 5.1 Diagnosis ...... 58
5.1.1 Subjective Assessments ...... 59 5.1.2 Disease Subtypes ...... 60 5.2 Treatment Overview ...... 63
5.2.1 Treatment of Acute Agitation Associated with Schizophrenia ...... 65 5.2.2 Maintenance Treatment of Schizophrenia ...... 66 5.3 US...... 67
5.3.1 Diagnosis ...... 67 5.3.2 Clinical Practice ...... 67 5.4 France ...... 68
5.4.1 Diagnosis ...... 68 5.4.2 Clinical Practice ...... 69 5.5 Germany ...... 70
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5.5.1 Diagnosis ...... 70 5.5.2 Clinical Practice ...... 70 5.6 Italy ...... 72
5.6.1 Diagnosis ...... 72 5.6.2 Clinical Practice ...... 72 5.7 Spain ...... 73
5.7.1 Diagnosis ...... 73 5.7.2 Clinical Practice ...... 73 5.8 UK...... 74
5.8.1 Diagnosis ...... 74 5.8.2 Clinical Practice ...... 75 5.9 Japan ...... 76
5.9.1 Diagnosis ...... 76 5.9.2 Clinical Practice ...... 76 6 Competitive Assessment ...... 78 6.1 Overview ...... 78
6.2 Strategic Competitor Assessment ...... 79
6.3 Product Profiles by Generation ...... 80
6.3.1 Conventional Antipsychotics ...... 80 6.3.2 Atypical Antipsychotics ...... 84 7 Opportunity and Unmet Need ...... 121 7.1 Unmet Needs Overview ...... 121
7.1.1 Public Awareness ...... 122 7.1.2 Early Diagnosis and Treatment ...... 124 7.1.3 Long-Acting and Advanced Drug Delivery Systems ...... 125 7.1.4 Effective Management of Negative and Cognitive Symptom Domains ...... 126
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7.2 Gap Analysis ...... 127
7.2.1 Long-Acting Drug Delivery ...... 128 7.2.2 Treatment of Negative and Cognitive Symptoms ...... 128 8 Pipeline Assessment ...... 129 8.1 Overview ...... 129
8.2 Clinical Trial Mapping ...... 130
8.2.1 Clinical Trials by Country ...... 130 8.2.2 Clinical Trials by Phase and Trial Status ...... 131 8.3 Early-Stage Pipeline Assessment ...... 132
8.4 Novel Therapeutic Approaches ...... 133
8.4.1 Negative Symptoms ...... 133 8.4.2 Cognitive Symptoms ...... 133 8.5 Long-Acting Drug Delivery ...... 134
8.6 Technology Trends Analysis ...... 134
8.7 Key Drugs in Clinical Development ...... 135
8.7.1 Aripiprazole Lauroxil ...... 137 8.7.2 Cariprazine ...... 142 8.7.3 Brexpiprazole ...... 146 8.7.4 Zicronapine ...... 150 8.7.5 Bitopertin ...... 153 8.7.6 EVP-6124 ...... 157 9 Current and Future Players ...... 161 9.1 Overview ...... 161
9.2 Trends in Corporate Strategy ...... 162
9.3 Company Profiles ...... 162
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9.3.1 Janssen Pharmaceuticals ...... 162 9.3.2 Eli Lilly and Company ...... 165 9.3.3 Roche ...... 167 9.3.4 Alkermes ...... 169 9.3.5 EnVivo Pharmaceuticals ...... 171 10 Market Outlook ...... 173 10.1 Global Markets ...... 173
10.1.1 Forecast ...... 173 10.1.2 Global Drivers and Barriers ...... 177 10.2 US...... 178
10.2.1 Forecast ...... 178 10.2.2 Key Events ...... 182 10.2.3 Drivers and Barriers ...... 182 10.3 France ...... 185
10.3.1 Forecast ...... 185 10.3.2 Key Events ...... 188 10.3.3 Drivers and Barriers ...... 188 10.4 Germany ...... 190
10.4.1 Forecast ...... 190 10.4.2 Key Events ...... 194 10.4.3 Drivers and Barriers ...... 194 10.5 Italy ...... 196
10.5.1 Forecast ...... 196 10.5.2 Key Events ...... 199 10.5.3 Drivers and Barriers ...... 200 10.6 Spain ...... 202
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10.6.1 Forecast ...... 202 10.6.2 Key Events ...... 205 10.6.3 Drivers and Barriers ...... 205 10.7 UK...... 206
10.7.1 Forecast ...... 206 10.7.2 Key Events ...... 209 10.7.3 Drivers and Barriers ...... 209 10.8 Japan ...... 211
10.8.1 Forecast ...... 211 10.8.2 Key Events ...... 214 10.8.3 Drivers and Barriers ...... 214 11 Appendix ...... 217 11.1 Bibliography ...... 217
11.2 Abbreviations ...... 233
11.3 Methodology ...... 238
11.4 Forecasting Methodology ...... 238
11.4.1 Diagnosis and Treatment Rates ...... 238 11.4.2 Adherence Rates ...... 239 11.4.3 Drugs Included in Each Therapeutic Class ...... 239 11.4.4 Launch and Patent Expiry Dates ...... 240 11.4.5 General Pricing Assumptions ...... 241 11.4.6 Drug Assumptions ...... 242 11.4.7 Generic Erosion ...... 249 11.4.8 Pricing of Pipeline Agents ...... 249 11.5 Key Opinion Leaders...... 251
11.6 About the Authors ...... 252
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11.6.1 Author ...... 252 11.6.2 Epidemiology ...... 252 11.6.3 Reviewers ...... 253 11.6.4 Global Head of Healthcare ...... 253 11.7 About GlobalData ...... 254
11.8 Disclaimer ...... 254
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1.1 List of Tables
Table 1: Symptom Clusters of Schizophrenia ...... 26
Table 2: ICD-9 Codes and Classification of Schizophrenia ...... 28
Table 3: Risk Factors and Comorbidities for Schizophrenia ...... 29
Table 4: Prevalence of Most Frequent Comorbidities in People with Schizophrenia and People without Schizophrenia, Both Sexes, Ages ≥18 Years, 2007 ...... 33
Table 5: Prevalence of Most Frequent Comorbidities in People with Schizophrenia and People without Schizophrenia, 1996–2001 ...... 34
Table 6: Distribution of Estimates of Schizophrenia from Three Meta-Analysis Studies of Incidence, Prevalence, and Mortality, by Sex ...... 37
Table 7: Trends in the Annual Incidence of Schizophrenia (per 100,000 Population), Portogruaro, Italy, 1982–1989 ...... 39
Table 8: Trends in the Prevalence of Schizophrenia (per 1,000 Population), Portogruaro, Italy, 1982–1989 ... 40
Table 9: Trends in the Prevalence of Schizophrenia (per 1,000 Population), Japan, 1984–2008 ...... 42
Table 10: Sources of Schizophrenia Prevalence Data ...... 43
Table 11: 7MM, Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, Ages ≥15 Years, N, 2012–2022 . 49
Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, N (Row %), 2012 . 51
Table 13: 7MM, Sex-Specific Diagnosed Prevalent Cases of Schizophrenia, Ages ≥15 Years, N (Row %), 2012 ...... 53
Table 14: Common Subjective Rating Scales Employed in Schizophrenia Diagnosis ...... 60
Table 15: Development-Based Classification of Antipsychotic Drugs ...... 63
Table 16: Receptor Binding Profiles of Atypical Antipsychotics ...... 64
Table 17: Guidelines for the Treatment of Schizophrenia ...... 65
Table 18: Leading Branded Treatments for Schizophrenia, 2013...... 80
Table 19: Strategic Competitor Assessment of the Marketed Products in Schizophrenia, 2014 ...... 80
Table 20: Chemical Classifications of FGAs ...... 81
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Table 21: Receptor Affinity Profiles for FGAs ...... 82
Table 22: First-Generation Antipsychotics SWOT Analysis, 2013 ...... 83
Table 23: Global Sales Forecast ($m) for First-Generation Antipsychotics, 2012–2022 ...... 84
Table 24: Product Profile – Abilify ...... 87
Table 25: Abilify SWOT Analysis, 2014 ...... 90
Table 26: Global Sales Forecast ($m) for Abilify, 2012–2022 ...... 91
Table 27: Product Profile – Saphris ...... 92
Table 28: Saphris SWOT Analysis, 2013 ...... 94
Table 29: Global Sales Forecast ($m) for Saphris, 2012–2022 ...... 95
Table 30: Product Profile – Clozaril ...... 96
Table 31: Clozaril SWOT Analysis, 2014 ...... 97
Table 32: Global Sales Forecast ($m) for Clozaril, 2012–2022 ...... 97
Table 33: Product Profile – Fanapt ...... 98
Table 34: Fanapt SWOT Analysis, 2014 ...... 100
Table 35: Global Sales Forecast ($m) for Fanapt, 2012–2022 ...... 100
Table 36: Product Profile – Latuda ...... 101
Table 37: Latuda SWOT Analysis, 2014...... 103
Table 38: Global Sales Forecasts ($m) for Latuda, 2012–2022 ...... 103
Table 39: Product Profile – Zyprexa ...... 105
Table 40: Zyprexa SWOT Analysis, 2014 ...... 108
Table 41: Global Sales Forecast ($m) for Zyprexa, 2012–2022 ...... 108
Table 42: Product Profile – Invega ...... 109
Table 43: Invega SWOT Analysis, 2013 ...... 111
Table 44: Global Sales Forecast ($m) for Invega, 2012–2022 ...... 111
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Table 45: Product Profile – Seroquel...... 112
Table 46: Seroquel SWOT Analysis, 2013 ...... 113
Table 47: Global Sales Forecast ($m) for Seroquel, 2012–2022 ...... 114
Table 48: Product Profile – Risperdal ...... 115
Table 49: Risperdal SWOT Analysis, 2013...... 117
Table 50: Global Sales Forecast ($m) for Risperdal, 2012–2022 ...... 117
Table 51: Product Profile – Geodon ...... 118
Table 52: Geodon SWOT Analysis, 2013 ...... 119
Table 53: Global Sales Forecasts ($m) for Geodon, 2012–2022 ...... 120
Table 54: Unmet Needs – Current Level of Attainment ...... 122
Table 55: Clinical Unmet Needs – Gap Analysis, 2013 ...... 127
Table 56: Schizophrenia – Clinical Trials by Phase and Status, Global, 2014 ...... 131
Table 57: Technological Trends Analytic Framework in the Schizophrenia Pipeline, 2014 ...... 135
Table 58: Pipeline Candidates in Development for Schizophrenia, 2014 ...... 135
Table 59: Comparison of Novel Therapeutic Classes in Development for Schizophrenia, 2013 ...... 136
Table 60: Product Profile – Aripiprazole Lauroxil ...... 137
Table 61: Aripiprazole Lauroxil SWOT Analysis, 2014 ...... 141
Table 62: Global Sales Forecast ($m) for Aripiprazole Lauroxil, 2012–2022 ...... 141
Table 63: Product Profile – Cariprazine ...... 142
Table 64: Cariprazine SWOT Analysis, 2014 ...... 145
Table 65: Global Sales Forecast ($m) for Cariprazine, 2012–2022 ...... 146
Table 66: Product Profile – Brexpiprazole ...... 147
Table 67: Brexpiprazole SWOT Analysis, 2014 ...... 149
Table 68: Global Sales Forecasts ($m) for Brexpiprazole, 2012–2022 ...... 149
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Table 69: Product Profile – Zicronapine ...... 150
Table 70: Zicronapine SWOT Analysis, 2014 ...... 152
Table 71: Global Sales Forecast ($m) for Zicronapine, 2012–2022 ...... 153
Table 72: Product Profile – Bitopertin ...... 154
Table 73: Bitopertin SWOT Analysis, 2014...... 156
Table 74: Global Sales Forecast ($m) for Bitopertin, 2012–2022 ...... 157
Table 75: Product Profile – EVP-6124 ...... 158
Table 76: EVP-6124 SWOT Analysis, 2014 ...... 160
Table 77: Global Sales Forecast ($m) for EVP-6124, 2012–2022 ...... 160
Table 78: Janssen Schizophrenia Portfolio Assessment, 2014 ...... 164
Table 79: Janssen SWOT Analysis, 2014 ...... 165
Table 80: Eli Lilly Schizophrenia Portfolio Assessment, 2014 ...... 167
Table 81: Eli Lilly SWOT Analysis, 2014 ...... 167
Table 82: Roche Schizophrenia Portfolio Assessment, 2014 ...... 168
Table 83: Roche SWOT Analysis, 2014 ...... 169
Table 84: Alkermes Schizophrenia Portfolio Assessment, 2014 ...... 170
Table 85: Alkermes SWOT Analysis, 2014 ...... 170
Table 86: EnVivo Schizophrenia Portfolio Assessment, 2014 ...... 171
Table 87: EnVivo Pharmaceuticals SWOT Analysis, 2014...... 172
Table 88: Global Sales Forecast ($m) for Schizophrenia, 2012–2022...... 175
Table 89: Global Schizophrenia Market, Drivers and Barriers, 2012–2022 ...... 177
Table 90: Sales Forecast ($m) for Schizophrenia in the US, 2012–2022 ...... 180
Table 91: Key Events Impacting Sales for Schizophrenia in the US, 2012–2022 ...... 182
Table 92: Schizophrenia Market in the US – Drivers and Barriers, 2012–2022 ...... 182
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Table 93: Sales Forecast ($m) for Schizophrenia in France, 2012–2022 ...... 186
Table 94: Key Events Impacting Sales for Schizophrenia in France, 2012–2022 ...... 188
Table 95: Schizophrenia Market in France – Drivers and Barriers, 2012–2022 ...... 188
Table 96: Sales Forecast ($m) for Schizophrenia in Germany, 2012–2022 ...... 192
Table 97: Key Events Impacting Sales for Schizophrenia in Germany, 2012–2022 ...... 194
Table 98: Schizophrenia Market in Germany – Drivers and Barriers, 2012–2022...... 194
Table 99: Sales Forecast ($m) for Schizophrenia in Italy, 2012–2022...... 197
Table 100: Key Events Impacting Sales for Schizophrenia in Italy, 2012–2022 ...... 199
Table 101: Schizophrenia Market in Italy – Drivers and Barriers, 2012–2022...... 200
Table 102: Sales Forecast ($m) for Schizophrenia in Spain, 2012–2022 ...... 203
Table 103: Key Events Impacting Sales for Schizophrenia in Spain, 2012–2022 ...... 205
Table 104: Schizophrenia Market in Spain – Drivers and Barriers, 2012–2022 ...... 205
Table 105: Sales Forecast ($m) for Schizophrenia in the UK, 2012–2022 ...... 207
Table 106: Key Events Impacting Sales for Schizophrenia in the UK, 2012–2022 ...... 209
Table 107: Schizophrenia Market in the UK – Drivers and Barriers, 2012–2022 ...... 209
Table 108: Sales Forecast ($m) for Schizophrenia in Japan, 2012–2022...... 212
Table 109: Key Events Impacting Sales for Schizophrenia in Japan, 2012–2022 ...... 214
Table 110: Schizophrenia Market in Japan – Drivers and Barriers, 2012–2022 ...... 214
Table 111: Key Launch Dates ...... 240
Table 112: Key Patent Expirations ...... 241
Schizophrenia - Global Drug Forecast and Market Analysis to 2022 20 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SCHIZOPHRENIA -
GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
1.2 List of Figures
Figure 1: 7MM, Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, Ages ≥15 Years, N, 2012–2022 . 49
Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, N, 2012 ...... 52
Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of Schizophrenia, Ages ≥15 Years, N, 2012 ...... 54
Figure 4: 6MM, Age-Standardized Diagnosed Prevalence (%) of Schizophrenia, Ages ≥15 Years, by Sex, 2012 ...... 55
Figure 5: Active Schizophrenia Clinical Trials by Location in the 7MM, 2014 ...... 130
Figure 6: Schizophrenia – Pipeline Drugs by Target, 2014 ...... 132
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012–2022 ...... 136
Figure 8: Schizophrenia Therapeutics – Pipeline by Company, 2014...... 161
Figure 9: Global Schizophrenia Drug Sales by Region, 2012–2022 ...... 176
Figure 10: Sales for Schizophrenia in the US by Drug Class, 2012–2022 ...... 181
Figure 11: Sales for Schizophrenia in France by Drug Class, 2012–2022 ...... 187
Figure 12: Sales for Schizophrenia in Germany by Drug Class, 2012–2022 ...... 193
Figure 13: Sales for Schizophrenia in Italy by Drug Class, 2012–2022 ...... 198
Figure 14: Sales for Schizophrenia in Spain by Drug Class, 2012–2022 ...... 204
Figure 15: Sales for Schizophrenia in the UK by Drug Class, 2012–2022 ...... 208
Figure 16: Sales for Schizophrenia in Japan by Drug Class, 2012–2022 ...... 213
Schizophrenia - Global Drug Forecast and Market Analysis to 2022 21 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2 Introduction
2.1 Catalyst
Schizophrenia is a chronic, severe, and disabling group of psychotic disorders characterized by fundamental disturbances of thinking such as hallucinations, delusions, disorganized communication and reduced motivation (NIMH, 2013; WHO, 2013). Globally, the condition is prevalent in approximately 7 persons per 1,000 of the adult population ages 15–35 years (WHO, 2013).
This report provides an overview of the risk factors, comorbidities, and the global and historical trends for schizophrenia in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). In addition, the report also includes a 10-year forecast of diagnosed prevalent cases of schizophrenia segmented by age and sex.
To forecast the diagnosed prevalent cases of schizophrenia in the 7MM, GlobalData epidemiologists selected nationally representative studies that provided diagnosed prevalence of schizophrenia using uniform diagnostic criteria and classification defined by the World Health Organization’s International Classification of Diseases 9th revision (ICD-9).
GlobalData epidemiologists forecast an increase in the diagnosed prevalent cases of schizophrenia in the 7MM from 2,495,903 diagnosed prevalent cases in 2012 to 2,643,660 diagnosed prevalent cases in 2022, with an annual growth rate (AGR) of 0.59% in the forecast period.
In 2022, the US will have the highest number of diagnosed prevalent cases of schizophrenia with 1,777,333 diagnosed prevalent cases, followed by Japan with 454,961 diagnosed prevalent cases, and Italy with 154,331 diagnosed prevalent cases.
Schizophrenia - Global Drug Forecast and Market Analysis to 2022 22 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2.3 Upcoming Reports
GlobalData (2014). PharmaPoint Report: Major Depressive Disorders, 2014
Schizophrenia - Global Drug Forecast and Market Analysis to 2022 23 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Appendix
11.7 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research, and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India, and Singapore.
11.8 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData.
Schizophrenia - Global Drug Forecast and Market Analysis to 2022 254 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.